Csv engineer Job at Algoteque (Boxmeer)

Csv Engineer

We are seeking a CSV Engineer with proven experience to manage validation delive...

Location

Italy , Sabaudia

Salary:

Not provided

S.T.B. ValiTech S.r.l.

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering or scientific fields is required
3-5 years of hands‑on experience in Computer System Validation within pharmaceutical, biotech, or other GxP‑regulated industries
Solid knowledge of GAMP 5 and Data Integrity principles
Proficiency in Microsoft Office
Availability to travel nationwide based on project requirements
Fluent Italian (mandatory)
Good English knowledge (written and spoken)

Job Responsibility

Lead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems
Draft and review System Configuration and system lifecycle documentation
Develop Computer System Validation Plans and Validation Reports
Drive Risk Assessment activities (RA, Data Integrity, Process Mapping)
Write and revise SOPs related to CSV and Data Integrity
Collaborate directly with client stakeholders (Engineering, QA, IT, Production)
Review Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers
Ensure alignment between user requirements, system design, and validation deliverables

What we offer

Competitive compensation based on experience
Meal voucher / client’s canteen
A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT)
Smart working authorized by the company for CSV activities suitable for remote execution
Continuous professional development and long-term career progression
Exposure to top-tier industry clients and innovative technologies

Fulltime

CSV Engineer

We are looking for a CSV Engineer to support a pharma project at a manufacturing...

Location

Netherlands , Boxmeer

Salary:

75000.00 - 80000.00 EUR / Year

Algoteque

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Computer Science, or another technical discipline
Experience working with automated systems and a solid understanding of automation fundamentals
Strong knowledge of cGMP, CSV, and SDLC methodologies
Excellent problem-solving, facilitation, and decision-making skills
Proven ability to analyze business problems, build business cases, and identify suitable process and technology solutions
Experience integrating vendor-packaged systems or equipment into a digital manufacturing environment

Job Responsibility

Support the operation and validation of automated systems within a pharmaceutical GMP environment
Apply CSV and SDLC methodologies to ensure systems comply with regulatory and quality standards
Analyze business and process requirements and contribute to effective technical solutions
Support the integration of vendor-packaged equipment into the site's digital and automation landscape
Collaborate with cross-functional teams to drive continuous improvement using LEAN/MPS/Six Sigma principles
Facilitate workshops, support decision-making, and contribute to validation and compliance documentation

Fulltime

CSV Engineer IV

The CSV Validation Engineer IV is responsible for authoring and reviewing valida...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Ten plus (10+) years of relevant computer systems validation, project management or operations experience within a cGMP environment, with at least 5 years of recent validation/engineering experience
Computer systems validation experience for GMP manufacturing, laboratory, quality, as well as utilities, and facilities
Experience in the biotechnology and/medical or pharmaceutical industry
Proficiency of Computers Systems Validation and Quality Systems
Good understanding of software supporting automated systems, laboratory equipment, and quality systems
Knowledge regulatory guidelines including 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
Experience in thorough testing of applications, computerized systems, changes and implementations
Excellent written and oral communication to include accurate and legible documentation skills
Ability to work in a fast-paced environment
Team oriented

Job Responsibility

Author and review validation deliverables within the Computer System Lifecycle (e.g. Validation Plans, SOPs, Protocols, Trace Matrix, Assessments, and Reports)
Participate in developing and revising validation procedures and protocols to meet regulatory requirements and site quality and validation procedures
Interact with CSV Management to prioritize and/or harmonize activities
Participate in multi-site CSV initiatives through document development or other validation activities
Author, review and approve system assessments, test documents, change controls, process improvements and compliance governance at all applicable points of the system life cycle for all PCI sites
Serve as the SME to provide compliance leadership and oversight for CSV projects
Collaborate with departments within the organization to maintain and improve computerized system validation processes
Generate, review and approve local validation and compliance documents supporting GxP computerized and computer systems, and relevant infrastructure
Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls
Execute validation protocols

Fulltime

CSV Engineer III

We’re looking for a CSV Validation Engineer III to join our Quality and Complian...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

5+ years of hands-on experience in a cGMP-regulated environment
At least 3 years focused on automation and validation
Strong knowledge of validation for manufacturing equipment, utilities, clean media systems, and facilities
Experience with industry standards like GAMP and regulations including 21 CFR Part 11, 210, 211, 820, and ICH Q7A
A deep understanding of system risk assessments, gap analysis, and remediation plans
Excellent communication and documentation skills
Team-first mindset with the ability to work independently on multiple complex projects
Proficiency in Microsoft Office and database systems

Job Responsibility

Lead validation activities throughout the computer system lifecycle
Develop test strategies, perform system assessments, and execute validation protocols for GxP systems and infrastructure
Ensure compliance with FDA (21 CFR Part 11, 820), cGMP, and global industry regulations
Collaborate cross-functionally with Manufacturing, QA, IT, and Engineering teams
Execute change controls and revalidation projects across systems such as PCS, BMS, CMS, OSI PI, and automation platforms
Train colleagues and contractors on best practices for computer system implementation and validation
Support periodic reviews and ensure the continued compliance of validated systems post-Go-Live

What we offer

A collaborative work environment where your ideas matter
Opportunities for cross-functional growth and leadership
Competitive compensation and benefits
A chance to shape critical systems that directly impact patient safety and product quality

Fulltime

Csv Junior Engineer

We are seeking a CSV Junior Engineer to support validation activities at one of ...

Location

Italy , Rome

Salary:

Not provided

S.T.B. ValiTech S.r.l.

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Engineering or scientific fields is required
0-3 years of experience in CSV, QA, IT/OT systems, automation, or other GxP‑related activities (internships included)
Good knowledge of English (written and spoken)
Proficiency in Microsoft Office
Strong motivation to grow in validation and regulatory compliance areas
Ability to work in a team and follow established procedures
Availability to travel frequently across Italy for project needs
Fluent Italian (mandatory)

Job Responsibility

Support the execution of qualification activities (IQ/OQ) for standalone and networked computerized systems
Assist in drafting System Configuration documents
Provide operational support to the client for IT infrastructure migration activities
Contribute to the preparation and execution of qualification protocols (FAT, SAT, IQ, OQ, PQ)
Support validation planning for computerized systems
Help in conducting Risk Assessments (RA, Process Mapping)
Draft and update Standard Operating Procedures (SOPs)

What we offer

Competitive compensation based on experience
Meal voucher / client’s canteen
A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT)
Smart working for agreed-upon CSV tasks
Continuous professional development and long-term career progression
Exposure to top-tier industry clients and innovative technologies

Fulltime

New

Qa Eng Manager

Location

Brazil , São Paulo

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Pharmacists with postgraduate qualifications in Engineering and relevant experience in Quality, Validation, and regulated environments, or similar experience
7+ years of experience in Quality, Engineering, Validation, or Manufacturing within regulated medical device and/or pharmaceutical environments
Strong working knowledge of validation/CSV, change control, utilities and facilities qualification, and quality systems
Experience supporting regulatory inspections and audits
Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, ICH Q7, and GAMP 5
Experience supporting combination products or multi-platform manufacturing sites
Familiarity with lean, continuous improvement, or business excellence systems in regulated environments

Job Responsibility

Provide QA oversight and governance for validation, change control, and lifecycle management of equipment, processes, utilities, facilities, and computerized systems across medical device and pharmaceutical operations, ensuring compliance with global regulatory standards (FDA, ISO, EU GMP, ICH, GAMP)
Review and approve validation, qualification, calibration, and change control documentation, ensuring systems remain in a state of control and risks to product quality, patient safety, and compliance are effectively managed
Support new product introductions, technology transfers, automation, digital solutions, and facility expansions, partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives
Oversee critical utilities, facilities, and metrology programs, ensuring systems are qualified, maintained, monitored, and inspection‑ready, with appropriate mitigation of deviations and out‑of‑tolerance conditions
Act as a key Quality partner during audits and inspections, drive standardization and simplification of QA Engineering processes, provide coaching and guidance to technical teams, and influence quality outcomes in a matrixed environment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Senior Specialist, Global IT Network

The resource will be responsible for the design, evolution, operation and securi...

Location

Italy , Pomezia; Milano; Alanno; Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Strong hands-on experience with Cisco networking (Catalyst, Nexus, ISR/ASR, Wireless LAN Controllers)
Hands-on experience with Cisco Meraki cloud-managed networking (MX security appliances, MS switches, MR wireless, Meraki Dashboard, Auto VPN and zero-touch provisioning)
Solid knowledge of routing and switching protocols (OSPF, BGP, EIGRP, STP, VLAN, VRF)
Experience with firewalling and network security (Cisco ASA/Firepower, Fortinet or equivalent)
Experience with SD-WAN and WAN optimization technologies
Knowledge of enterprise Wi-Fi design and management
Solid knowledge of server virtualization on both Microsoft Hyper-V and VMware vSphere/ESXi (vCenter, clustering, HA/DR)
Experience with hyperconverged infrastructure (HCI) platforms (VMware vSAN, Nutanix, Azure Stack HCI / Azure Local)
Working knowledge of Microsoft Azure and hybrid-cloud services (Azure Arc, hybrid connectivity, Azure VMware Solution)
Ability to manage the end-to-end lifecycle of systems and infrastructure (deployment, patching, upgrades, capacity and decommissioning)

Job Responsibility

Design, configure and maintain enterprise networks based on Cisco technology (routing, switching, VLAN, VRF, spanning-tree)
Manage WAN/SD-WAN connectivity, MPLS and inter-site links, including performance and capacity management
Administer data center networking (core/distribution/access, Nexus, fabric architectures)
Manage enterprise wireless infrastructure (controllers, access points, site surveys, coverage optimization)
Configure and operate perimeter and internal firewalls, network segmentation and IT/OT segregation
Implement and maintain network security controls (NAC, 802.1X, ACL, micro-segmentation, hardening)
Support secure remote access and VPN architectures
Manage the full lifecycle of network systems and devices (provisioning, configuration, firmware/patching, upgrades, capacity management and secure decommissioning)
Monitor network performance, availability and capacity
manage incidents and root-cause analysis

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Fulltime

New

Associate IS Engineer - Salesforce

As an Associate IS Engineer at Amgen, you will be responsible for developing and...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s/master’s degree and over 2-6 years of Computer Science, IT or related field experience
Proficient in developing custom solutions using Salesforce Lightning Components (Aura and LWC), Apex classes, Visualforce pages, and Apex triggers, including batch classes and schedulers with exception handling
Experience configuring standard/custom objects, fields, page layouts, validation rules, roles, profiles, permission sets, and region-specific sharing and access models
Hands-on experience integrating Salesforce with internal and external systems using REST and SOAP APIs
familiarity with middleware for system interoperability
Familiarity with DevOps tools, version control systems (e.g., Git), and CI/CD pipelines beyond Copado, contributing to efficient and traceable deployments
Strong analytical mindset with the ability to troubleshoot platform issues, optimize performance, and explore emerging Salesforce features for continuous improvement
Willing to learn and seek for knowledge and contribute for the team’s progress and personal development
knowledge on helping the stakeholders with the report’s generation using Salesforce reporting functionality
Knowledge on creating rubric for prioritization and scoring of various elements in the applications

Job Responsibility

Design and implement Salesforce Lightning components using LWC and Aura frameworks to enhance platform functionality and user experience
Configure roles, profiles, permission sets, and region-wise security and sharing settings to ensure appropriate access control across user groups
Create and customize standard and custom objects, page layouts, validation rules, record types, and formula fields to meet business requirements
Develop and maintain Apex classes, triggers, Visualforce pages, and custom controllers as needed
Design and implement integrations between Salesforce and external/internal systems using REST/SOAP APIs and middleware
Utilize Copado deployment tools to manage source control, deployments, pipeline automation, and environment management in support of release processes
Apply Salesforce development best practices to ensure code reusability, maintainability, and compliance with performance and scalability standards
Troubleshoot and resolve development or configuration issues during lower environments and production support cycles
Participate in design reviews, sprint planning, and code reviews, contributing to Agile/Scrum ceremonies and delivery cycles
Maintain documentation including technical design, solution architecture, and release notes when required for enhancements and projects

Fulltime

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Csv engineer

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